The M3 Checklist & Clinical Practice

The M3 Checklist & Clinical Practice What It Is Why It s Needed How to Use It 155 Gibbs Street, Suite 522 Rockville, MD 20850 Version 1 301.444.4400 M3Information.com

Special Communication USPSTF Recommendation Statement Screening for Depression in Adults US Preventive Services Task Force Recommendation Statement 34 Sui A, et al, 2016. Screening for Depression in Adults US Preventive Services Task Force Recommendation Statement. JAMA 2016:315(4):380 T he USPSTF recommends screening and behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings. Screening Tests Treating depressed adults and older adults identified through screening in primary care settings with antidepressants and/or psychotherapy decreases clinical morbidity. USPSTF also found that programs combining depression screening and feedback with staff assisted depression care supports improve clinical outcomes in adults. There is fair evidence that screening and feedback alone without staff-assisted care supports do notimprove clinical outcomes in adults. All positive screening results should lead to additional assessment that considers severity of depression and comorbid psychological problems (e.g. anxiety, panic attacks, or substance abuse), alternate diagnoses, and medical conditions. Patients who screen positive should be appropriately diagnosed and treated with evidence-based care or referred to a setting that can provide the necessary care. The USPSTF found adequate evidence that the magnitude of harms of screening for depression in adults is small to none.

Measurement & Evidence-Based Mental Health Care The M3 Checklist screening assessment & tracking tool is: Take the Test Evidence-based User-friendly Administered on the web or a mobile device Instantly interpreted M3 Detects Risk for: Depression Anxiety disorders Bipolar disorders Post-traumatic stress disorder Substance Misuse Suicidality Functional Impairment It fits into practice workflow, yields standardized reports, and connects with most electronic health records (EHRs). Information developed through the M3 Checklist provides a comprehensive profile of each patient, including functional status, drug use, and thoughts of suicide. The information can be used in measurement-based care, revealing changes in a patient s mental health status, practice patterns, and aggregate population health data. 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 3

M3 Checklist Why It s Needed & How to Use It Contents 5 About M3 Checklist The evidence for treatment of MH disorders is clear. Left untreated or undertreated, they are costly and confound care of comorbid conditions. The patient-rated M3 Checklist through LabCorp assesses multiple mental health conditions while providing data. 6 Mental Health is More Than Depression Alone Over half of Americans will have a mental health disorder in their lifetime. Often individuals will have overlapping conditions, such as anxiety coupled with depression. 7 Cost of Mental Illness Mental health conditions are the largest drivers of health care costs, totaling $293 billion annually. The prevalence of anxiety is almost twice that of depression. 8 One Number Risk for four mental health disorders can be recognized through one number, which is similar to diabetes risk identification using A1C. 9 Interpreting the M3 Checklist & the AUDIT-C M3 reports are like any other LabCorp report, making it easy to accurately identify risk for a diagnosis and treat the patient. 12 M3 Mental Health Advisor 13 Integration into Clinical Workflow These LabCorp based assessments (M3 Checklist & AUDIT-C) enhance patient care and return results to the electronic health record without creating additional clinical workflow burden. 14 The Spectrum of Mental Health Screens M3 is web-based, screens for a minimum of 5 conditions, provides data to the electronic health record, and takes minutes to complete. In one package, it offers much more than other common screens. 15 Comprehensive List of Codes & Reimbursement for Mental Health Assessments Codes are identified for these mental health services and when used, can add significantly to a practice s bottom-line. 16 Population Health Workflows for Mental Health 17 Use Cases The M3 Checklist can be used in primary and specialty care practices, help collection of quality reporting metrics, and provide data to illuminate the problem of rehospitalization. 18 Sustainability of Mental Health Screening in Primary Care Assessment and treatment of mental health conditions is financially sustainable. 19 M3 Resource Allocation Map for Behavioral Health 20 FAQ s 22 References 23 Appendix A. Validation Study 4 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

About M3 Checklist LabCorp is now offering the M3 Checklist, empowering providers with an evidencebased assessment that detects symptoms of mental health conditions: depression, anxiety, bipolar disorders, PTSD and an option for substance misuse. The Checklist is a nationally recognized, peer reviewed and clinically validated tool. 1 Once the patient completes the assessment, the M3 Checklist computes results and sends a report to the ordering clinician. The report provides a numeric value, the M3 score, indicating the overall level of mental health symptom burden. Functional impairment and symptom severity for each of mental health conditions are also identified. Out of range scores are flagged as high so there can be further review with the patient to determine clinical needs. 1 in 5 U.S. adults suffer from one or more mental health disorders 2 7 different disorders and features of mood & anxiety disorders Anxiety Depression PTSD Suicide Bipolar disorder Substance Misuse Functional Impairment <50% never get help 3 45 Million suffer from anxiety 4,5 27 Questions on the test 29% adults with a chronic medical condition have a mental illness 6 20% of rehospitalizations are impacted by mental illness 7 EMR Data is sent directly to the EMR 10% suffer from depression 3 Who Should Use the M3 Checklist? Primary care practitioners Specialty care physicians Patient centered medical homes Accountable care organizations Federally qualified health centers Mental health professionals Behavioral health clinics Integrated delivery networks Commercial & government payers Employee assistance programs 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 5

Mental Health: More than Just Depression Anxiety disorders, depression, and bipolar disorders represent 99 percent of mental health conditions. Research shows that 55 percent of Americans will experience a mental health disorder in their lifetime (see Figure 1). Anxiety disorders are nearly two times more prevalent than depression. Yet, practices that use screening tools typically assess only for depression. For this reason, and because mental health conditions frequently present together, this common approach often results in underdiagnosis and under-treatment. The M3 Checklist identifies symptoms of anxiety disorder, bipolar disorder, depression, and PTSD, providing a profile showing the presence of any of these conditions in every screened individual. Figure 2 indicates the diagnoses of the participants in the M3 validation study and shows where many had one or more mental health condition. Fig. 1: Lifetime Prevelance 8 55% of Americans will suffer from a mental disorder during their lifetime. Social phobia Generalized anxiety disorder Obsessive-compulsive Separation anxiety Mood disorder Major depression 12.1% 5.7% 1.6% 5.2% 20.8% 16.6% Fig. 2: M3 Validation Study Demonatrates the Overlapping Nature of Mental Health Condition 1 Dysthymia 2.5% Disorder Lifetime Prevalence Bipolar I or II Post-traumatic stress disorder Substance misuse disorder 3.9% 6.8% 14.6% Any anxiety disorder 28.8% Alcohol abuse 13.2% Panic Disorder 4.7% Alcohol dependence 5.4% Agoraphobia without panic 1.4% Drug abuse 7.9% Specific phobia 12.5% Drug dependence 3.0% 6 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

Cost of Mental Illness Payers PMPM without MH Diagnosis % Patients with Diagnosis PMPM with MH Diagnosis Increase with MH Diagnosis $26 to $48 billion can Commercial $340 14% $903 266% Medicare $582 9% $1,409 242% Medicaid $381 20% $1,301 341% All Insurers $397 14% $1,085 273% Potential Savings in Chronic Condition Care through Treating Co-occuring Mental Illness 9 be saved through effective integration of mental health and medical services. 9 Medical Condition Total Commercial Costs (Million) Total Medicare Costs (Million) TOTAL SAVINGS Arthritis $36,372 $11,929 Asthma $30,801 $2,570 Cancer $16,201 $3,535 Hypertension (without complications) $27,241 $9,620 Ischemic Heart Disease $7,208 $7,278 Total Commercial Costs (Million) $162,366 Total Medicare Costs (Million) $30,803 *Please note that the values do not sum to create the total 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 7

The M3 Score: One Number for Mental Health The M3 Checklist captures a comprehensive measure of a patient s overall mental health symptom burden. This is done by assessing a patient s risk of common mental health conditions found in primary care: depression, anxiety, bipolar disorder, and post-traumatic stress disorder. The validation study out of the University of North Carolina 1 identified symptom burden scores for each of the four diagnoses. Of the 647 participants enrolled in the study, any positive M3 sub-score reflects 83% sensitivity and 76% specificity for risk of a diagnosable condition. Further evaluation of the original study data was performed to determine whether a single number, the M3 Checklist Score or M3 Score, could quickly indicate whether the patient is at significant risk of any mood or anxiety disorder, singly or in combination. This unpublished analysis 10 demonstrated that the optimal screening cut point is a score of 33 and above. With this additional data, the Checklist has a positive predictive value of 71%, indicating patients at risk for four mental health disorders (not merely depression), while 89% of patients with a score of 33 or less are diagnosis free. Consequently, scores of 33 or above are considered out of range and are therefore flagged as high on the report. The M3 Score also correlates well with the Short Form Health Survey (SF-12), a standard in the field, which is a brief, functional health survey that assesses limitations on role functioning as a result of physical and emotional health. These correlations are further proof of the M3 s ability to find clinically significant cases where there is demonstrable functional impairment. 11 The National Institute of Mental Health has endorsed a more multi-dimensional approach to psychiatric illness, 12,13 suggesting that symptoms from across a range of common diagnostic categories should be assessed. This is the approach the M3 takes. The first step in using the M3 Checklist is to determine whether the M3 score is in or out of range. Look next to the four subscores, also flagged when results indicate the patient may be at risk for each of the four disorders. Finally, in considering a diagnosis it is important to look at the patient s functional status, reflected in the M3 Gateway responses. A positive Gateway, combined with significant symptom severity, provides the criteria for a mental health diagnosis from which primary care physicians can initiate treatment, whether it be psychotherapy, pharmacotherapy, or both. The M3 also contains two additional questions probing for alcohol and substance misuse. When endorsed by the patient, alcohol use patterns may be further investigated with the AUDIT-C, an instrument available to order along with the M3 Checklist. 20 40 59 60 28 36 47 10 14 8 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

How to Review the M3 Checklist Report This lab report is organized like any other LabCorp report. The left-hand column entitled TESTS shows requested assessment results for the M3 Checklist and/or the AUDIT-C. The RESULT column displays overall findings relative to the results of the assessment, e.g. M3 Score, M3 Gateway, Diagnosis Risk by condition, Gateway Questions, Symptom Severity Subscores by condition, and responses to Questions. FLAG identifies out-of-range scores, which are either HIGH or blank. Items flagged as HIGH are bolded and suggest the need for special attention to better understand the nature of the patient s response and how they relate to the relevant mental health condition. The REFERENCE INTERVAL identifies the expected baseline range for each item. 1 M3 Score indicates the overall level of mental health symptom burden. 0-32=low; 33-108=high M3 Gateway, when positive, indicates impairment in functional status. The Gateway is positive if any of the five Gateway questions (Q5 & Q24-27) are positive. 2 Diagnosis Risk A psychiatric diagnosis requires significant impairment in function, which is indicated by a positive Gateway. A sufficient level of symptoms is also required to meet diagnostic criteria for any condition. Generally, each Diagnosis Risk incorporates both requirements into its result. 1 2 3 4 3 The Gateway Questions (questions 5 and 24 through 27) address functional status, substance use, and thoughts of suicide. Positive answers to these questions should be followed by additional questions to understand what the patient means, if this is a change, and to determine need for further intervention. Suicide assessment is included to minimize risk when treating mood and anxiety disorders. 5 4 Symptom Severity indicates the severity of symptoms for each of the four clinical conditions and is not impacted by the Gateway result. These subscores are most sensitive to change over time, and their review should be combined with discussing of the responses for each condition. 1 of 3 5 The 27 Questions and responses inform how the clinician focuses on further assessment after reviewing the report. Responses flagged as HIGH have the highest severity and should be reviewed in more detail with the patient. The following question numbers indicate which questions apply to each condition. Depression: 1-7 Anxiety: 8-19 (GAD 8-9; Panic 10-11; Social 12; OCD 17-19) PTSD: 13-16 Bipolar: 20-23 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 9

Sample LabCorp Report Highlighting the M3 Scores (continued) 59 2 of 3 3 of 3 10 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

How to Review the AUDIT-C Report The AUDIT-C identifies people at high risk for Alcohol Use Disorder. This report is organized like any other LabCorp report. The left-hand column entitled TESTS lists the queries for the AUDIT-C (e.g. question 1). The RESULT column displays overall findings relative to the results of the assessment (e.g. Positive). FLAG identifies out-of -range scores, which are either HIGH or blank. Items flagged as HIGH are bolded and suggest the need for special attention to better understand the nature of the responses and how they relate to alcohol use. The REFERENCE INTERVAL identifies the expected baseline range for each item. 1 AUDIT-C Total Score A positive test is a total score of 3 or higher (some use 4 as the threshold for men) or any response to Q3 other than Never. 2 Questions The response to each question can be reviewed. Responses inform the clinician how to focus further assessment of the patient. These questions relate to frequency, and quantity of alcohol use, and the presence of binging behavior. Any positive response to Question 3, despite a negative overall result, warrants further questioning. 1 2 3 LabCorp Laboratory Corporation of America M 3 Information LLC 155 Gibbs Street Suite 522 Rockville, MD 20850 0392 Phone: 301-444-4414 301 444 4400 Specimen Number Patient ID Control Number Account Number Account Phone Number Route 122 M32 0001 0 123123123 123123123 74320006 336 436 8272 50 Patient Last Name Account Address LABCORP Paul Testing Acct Patient First Name Patient Middle Name TESTTHREE Vice Testing Patient SS# Patient Phone Total Volume 3060 S CHURCH ST KOURY CTR BURLINGTON NC 27215 Age (Y/M/D) Date of Birth Sex Fasting 18/05/21 11/11/98 M Date and Time Collected 05/02/17 15:10 AUDIT C Patient Address Date Entered 05/02/17 Date and Time Reported 05/02/17 16:52ET Tests Ordered Additional Information KAREN@M3INFORMATION.COM Physician Name GREENFIEL, D NPI 2000000001 Physician ID TESTS RESULT FLAG UNITS REFERENCE INTERVAL AUDIT C Assessment Date/Time 05/02/2017 03:19PM EDT AUDIT C Positive High Negative AUDIT C Total Score 5 High 0 2 Q1 How often in past year 4+ weekly Q2 How many on a typical day 3 4 drinks Q3 6+ drinks per occasion Never Never Comments: A) AUDIT C identifies people at high risk for heavy drinking (6+ at once) or for alcohol use disorder. A Positive test is a total score of 3 or higher (though some use 4 or higher for greater specificity [1]). The highest total score is 12. B) Any positive response to Q3 despite a Negative test suggests further questioning. C) For risk of heavy drinking, sensitivity is 0.98 and specificity is 0.57. For risk of alcohol use disorder, sensitivity is 0.90 and specificity is 0.45. Reference: [1] Bush et al., 2003. The AUDIT Alcohol Consumption Questions (AUDIT C). Arch Int Med 158:1789 95. Disclaimer: This is not intended as a medical or other professional service, and the use of the M 3 Checklist or any other M3 materials is not intended to create, and does not create any medical or other professional services relationship. Use of the M 3 Checklist and other M3 materials is not an adequate substitute for obtaining medical or other professional advice, diagnosis or treatment from a qualified licensed healthcare provider. The M 3 Checklist and other M3 materials are provided 'as is' without any warranties of any kind, either express or implied, and M3 disclaims all warranties including liability for indirect or consequential damages. M3 Checklist was developed by M3 Information, and the LAB 01 01 01 01 01 01 01 01 01 M 3 Information LLC LabCorp 155 Gibbs Street Suite 522 Laboratory Corporation of America Rockville, MD 20850 0392 Phone: 301-444-4414 301 444 4400 Patient Name Specimen Number LABCORP, TESTTHREE 122 M32 0001 0 Account Number Patient ID Control Number Date and Time Collected Date Reported Sex Age(Y/M/D) Date of Birth 74320006 123123123 123123123 05/02/17 15:10 05/02/17 M 18/05/21 11/11/98 TESTS RESULT FLAG UNITS REFERENCE INTERVAL LAB assessment is made available through LabCorp, its exclusive US distributor. M 3 Checklist (c) 2010, M 3 Information, LLC PDF Image. 01 SPACE 01 M3IMD M 3 Information LLC Gerald,Hurowitz, Dir: Steve Daviss, MD MD 155 Gibbs Street Suite 522, Rockville, MD 20850 0392 For inquiries, the physician may contact Branch: 800 762 4344 Lab: 301 444 4400 301-444-4414 LABCORP, TESTTHREE 123123123 05/03/17 08:25 ET DUPLICATE FINAL REPORT This document contains private and confidential health information protected by state and federal law. If you have received this document in error, please call 800 222 7566 122 M32 0001 0 Seq # 0000 Page 1 of 2 2004 17 Laboratory Corporation of America Holdings All Rights Reserved DOC1 Ver: 1.49 LABCORP, TESTTHREE 123123123 05/03/17 08:25 ET DUPLICATE FINAL REPORT This document contains private and confidential health information protected by state and federal law. If you have received this document in error, please call 800 222 7566 122 M32 0001 0 Seq # 0000 Page 2 of 2 2004 17 Laboratory Corporation of America Holdings All Rights Reserved DOC1 Ver: 1.49 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 11

M3 Mental Health Advisor Patient Name: Provider Name: Testing, Minnie J M3 Info. Testing Account DOB: 03/08/1955 (Age 62) ID: 922-729-4355-6 Gender: Female Collected: 5/17/17, 09:35 Reported: 5/17/17 Observations The M3 Score is 40 (moderate level of symptoms) with medium level impairment due to alcohol use, thoughts of suicide sometimes, and significant impairment at work, with some at home, too. Minnie has a high positive risk of having a current major depression diagnosis, with a lower positive risk of an anxiety disorder, possibly generalized anxiety disorder. Risk of having bipolar disorder or PTSD is low. He is drinking alcohol heavily. Depression symptoms are at the severe level (M3 Depression score = 20), w mild level of anxiety symptoms (M3 Anxiety score = 11). Intervention strongly advised. Treatment Options Guideline recommendations suggested for those with similar symptoms include medication, psychotherapy, and brief intervention and referral for alcohol use. If a prior depression medicine has been effective, this can be considered. Minnie s symptom profile shows anergia and insomnia to be most severe, followed by depressed mood, concentration, anhedonia, and worrying. Medications suggested as first line include SSRIs, SNRIs, and bupropion. Alcohol cessation may carry risk of withdrawal and seizure, so assessment of risk and education on withdrawal symptoms and management with short course of long halflife benzodiazepines may be considered, which may also help with insomnia. Cognitive-behavioral therapy referral is recommended per guidelines. M3 Score: 40 (High) Reference Range: 0-32 M3 Gateway: Positive-Med Depression Treatment Timeline 16 Relationship Between Mental & Physical Health Indicators 1/15 2/15 3/15 4/15 5/15 6/15 7/15 8/15 Subscores Anxiety 48 Reference Range: Negative A weekly assessment is recommended until symptom severity begins to decrease. With adequate medication dosage and adherence, symptom subscores may begin to decrease after 2-3 weeks. Goal is M3 Depression score less than 15 within 1-2 weeks, and less than 7 within 4-6 weeks. Monitor for increase in Anxiety or Bipolar Symptom scores, which can be medication side effects. M3 Score Body Mass Index Hgb A1c Blood Pressure Out of range In Range Depression Bipolar Disorder PTSD 28 16 Care Considerations 12 36 21 12 Assessment of suicide risk is the first priority. With an acceptable safety plan, further diagnostic assessment includes duration of symptoms and ruling out medical causes, including medication side effects. If specialty consultation is available, it should be considered. 8 4 0 1/15 3/15 5/15 7/15 8/15 18 12 0 1/15 3/15 5/15 7/15 8/15 14 7 0 1/15 3/15 5/15 7/15 8/15 8 4 0 1/15 3/15 5/15 7/15 8/15 12 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

M3 Checklist Workflow These assessments are ordered the same way as any LabCorp specimen test Primary care physicians do not want to do more work and especially without getting paid for it. The M3 Checklist and the AUDIT-C easily fit into clinical workflow and are reimbursed by Medicare and many commercial insurers. These assessments are ordered the same way as any LabCorp specimen test and, once completed on-line by the patient, the reports are integrated into the electronic health record for review of out of range values by the clinician, with the patient. 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 13

Comparison of Assessments In one assessment, the M3 checklist offers more than other common mental health screens. It assesses for over 5 mental health disorders, is webbased, provides structured data directly to the electronic health record and takes minutes to complete. M3 Checklist AUDIT-C GAD-7 PHQ-9,4,2 DAST-10 DASS-21 MDQ SF-20 No. of Questions 27 3 7 9,4,2 19 21 13 20 Time to Complete 3-5 mins. 1 min. 2 mins. Depression 3,2,1 min(s). 3 mins. 7 mins. 5 mins. 7 mins. Bipolar Anxiety 4&9 PTSD Substance Misuse Functional Impairment Data sent to EHR Suicide 14 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

Comprehensive List of Codes & Reimbursement for Mental Health Assessments Type of Assessment Payer Code Type Billing Code Description Estimated Reimbursement Medicare/ Commercial CPT 22 96103 Psychological testing, administered by a computer, with qualified health care professional interpretation and report. $30.95 23 $28 24 & $30 25 to $60 25 Medicare HCPCS 26, 27 G0444 Annual depression screening, 15 minutes. No co-insurance, no co-pay $21.06 23 Mental Health Assessments Medicare/ Commercial Commercial CPT 22 CPT 22 96127 96160 96161 Brief emotional/behavioral assessment with scoring and documentation, per standardized instrument. Up to 4 units can be billed per day $6.94 23 Administration of patient-focused health risk assessment instrument (e.g., health hazard appraisal) with scoring and documentation, per standardized instrument. Administration of caregiver-focused health risk assessment instrument (e.g., depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument $ 5.62 23 $ 5.62 23 Alcohol Assessments Medicare HCPCS 26, 28 G0396 Alcohol and/or substance (other than tobacco) abuse structured screening $37.51 23 and brief intervention services (SBIRT); 15 to 30 min Commercial CPT 22, 29 99408 $33.41 29 G0442 Annual alcohol misuse screening in adults, 15 min. Preventive service: no coinsurance, no deductible for patient. $21.04 23 26, 30 Medicare HCPCS G0443 Brief face-to-face behavioral counseling interventions for individuals who screen positive for alcohol misuse 15 min. No coinsurance, no deductible, no co-pay $29.09 23 Collaborative Care Model Codes 26, 31 Medicare HCPCS G0502 Initial psychiatric care management, 70 min. $162.80 23 G0503 Subsequent psychiatric care management, 60 min $143.84 23 G0504 Initial/subsequent psychiatric care management, additional 30 min $75.07 23 G0507 Care management for behavioral health conditions services, minimum 20 min, directed by a physician. $54.17 23 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 15

16 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

Use Cases Logic How Often to Administer Annual Physical Annual review to see if there is a problem 27 Once a Year unless there are signs during the year 32 M3 Information Use Cases The multi-condition mental health assessment, the M3 Checklist, can be used to identify and monitor mental health symptoms in many settings, as seen to the right. Alone or in the presence of comorbid medical conditions, mental health disorders often interfere with patients adherence to treatment and impair their ability to function at home and work. Detection, treatment, and monitoring of patients mental health conditions in many settings enhances function, improves outcomes, and decreases rehospitalizations. Monitoring those in therapy or receiving medication Readmission reduction efforts Behavioral Health / Employee Assistance Monitor progress to adjust treatment to improve outcomes 33 Mental illness increases the chances of readmissions 35 Minimize absenteeism 36, 32 and presenteeism 43.6 million patients have dealt with a mental disorder in the past year. USPSTF suggests using clinical judgment in consideration of risk factors to determine if additional screening is warrented 34 Depression and mental illness are responsible for up to 20% of rehospitalizations (at discharge) 35 Every 6 to 12 36, 32 months routinely Specialty Settings High rates of mental illness and physical illness 7, 37 comorbidity OB/GYN (Post Partum) 6, 34 Endocrine (Diabetes, Hypothyroidism) 7, 37 Cardiology (Myocardial 7, 37 Infarction) Neurology (Stroke, TBI, 7, 37 Epilepsy) (Annually) 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 17

Sustainability of Mental Health Screening in Primary Care One in five patients may harbor diagnosable mental illness. 2 Primary care is the first line of defense in identification of these disorders. The majority of mental health visits occur with primary care physicians, and these same professionals write the bulk of antidepressant and antianxiety prescriptions for mood and anxiety disorders. 1 The M3 Checklist, an evidence-based and validated multi-condition mental health screening tool, enables LabCorp to help physicians identify patients that can benefit from treatment. This schedule uses practice information, annual prevalence rates of behavioral health disorders and current CPT codes to project costs and revenues for primary care practices implementing routine annual mental health and alcohol use disorder assessments. Two billing codes are used in this model: 96103 for the M3 Checklist, a computer based multi-condition mental health assessment G0442 for an annual preventive service alcohol screen Patients whose scores are out of range for either assessment would receive follow-up care for three months. Progress is monitored through a monthly follow-up assessment for these three months. Adjustment to care is informed by changes to the M3 Checklist and AUDIT-C scores. It is estimated that out of a practice of 1,500 patients, approximately 238 would be at risk for a mental health condition and would require further treatment. Implementing annual screens for a panel of patients with serial assessments of those patients with a mental health diagnoses would generate $34,650 in annual income. Model Elements Assumptions Annually Model Number of Providers 1 1 Patients in Provider Panel 1,500 1,500 Patients Receiving MH Assessment 70% 1,050 Percent of Patients at Risk of MH condition 2 16.7% 175 Percent of Patients at Risk for Alcohol Misuse 2 6% 63 Percent of Patients with Both MI and AUD 2 3.3% 8 Patients at Risk of BH Conditions - 238 Number of Assessments for Identification - 1,050 Reimbursement per review for 96103 3 $30 $31,500 Reimbursement per review for GO442 3 $21 $22,050 Total Reimbursement for MH and SUD Review) $51 $53,550 Cost to Administer Assessments $18 $18,900 Net Income from Assessment Effort $33 $34,650 18 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

M3 Resource Allocation Map for Behavioral Health: 3 Paths to Direct Care-Management Teams Stratification by Cost Stratification by Percent of Total Patients Target Population These 45% of patients are responsible for 57% of total costs to the mental healthcare system. They benefit quickly from brief managed care interventions. 57% 50% of patients will be virtually nonsymptomatic or low-cost for behavioral health 30% 45% of patients should benefit from collaborative care and care management 5% of patients are complex cases. These patients are very expensive to care for and resource-dependent on government funds and regulations. 3% Chronic At Risk (M3 <33; with impairment) Healthy (M3 Score < 33; No impairment) Chronic At Risk (M3 <33; with impairment) Healthy (M3 Score < 33; No impairment) 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 19

Frequently Asked Questions 1. What are Mood and Anxiety Disorders? A mood disorder 38 is any of several psychological disorders characterized by the elevation or lowering of a person s mood, such as depression and bipolar disorder. There are various anxiety disorders 38, such as panic disorder, obsessive-compulsive disorder, a phobia, or generalized anxiety disorder. These disorders are characterized by excessive or unrealistic anxiety about two or more aspects of life. Changes related to mood or anxiety disorders are typically distressing to the individual and their family and often impair work and school performance. 2. How Many Americans Suffer from Mood and Anxiety Disorders? According to the most recent national survey by the federal Substance Abuse and Mental Health Services Administration (SAMHSA), 1 in 5 US adults suffer with a mental condition. 2 Annually, anxiety disorders affect 18 percent of adults and depression impacts nearly 10 percent. 3 20 percent of patients diagnosed with depression are in fact suffering from bipolar disorder. 5 Unfortunately, less than 50 percent of patients receive any help for these mental health conditions. 4 3. What is the M3 Checklist? The M3 Checklist is a 27-question, webbased, patient-rated checklist for symptoms of depression, anxiety, bipolar disorder, suicidality, and substance misuse that takes 5 minutes or less to complete. Responses to the Checklist are quantified and calculated into an individual s risk of suffering from a mental health condition. Reports are sent directly to the electronic health record in the typical LabCorp report format, which highlights outof-range responses. The information provided by the M3 Checklist report facilitates doctorpatient discussion of relevant mental health issues during their office visit. The Checklist directs the clinician toward a diagnosis and helps patients be aware of their mental health needs. 4. What is the AUDIT-C? The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) 14 is a brief, 3-question, validated screen for risky drinking and alcohol misuse and dependence. 5. Who can Benefit from Taking the M3 Checklist? Anyone 18 years or older may complete the M3 Checklist, and the results can help that person identify and track any symptoms it may reveal. Clinicians and health care practices can benefit from the M3 Checklist by gaining access to a more comprehensive understanding of each patient s clinical presentation. This is especially valuable for primary care practices, because undiagnosed or under-treated mood, anxiety, and alcohol use disorders can delay or block responses to medical therapies and often result in worse outcomes for comorbid chronic medical conditions, the costs of which double with comorbid behavioral health conditions (and 80 percent of those excess costs are on the medical side). 37 Within the tight time constraints of a typical office visit, the Checklist provides an algorithm for upto-date, evidence-based treatment of mood and anxiety disorders that might otherwise go untreated. 6. How Does the M3 Checklist Help Ensure Appropriate Mental Health Care? The M3 Checklist is not designed to diagnose mental illness on its own. Rather, it is meant to elicit a symptom profile that may indicate a psychiatric illness. Physicians must use the symptoms checklist responses and risk assessment provided as a basis for formulating a diagnosis and treatment. 7. How Often Will Patients Complete the M3? After patients complete the initial screen and have begun appropriate treatment and/or therapy, they should be screened monthly to monitor changes in the Checklist total score and sub-scores. Subsequent assessments may 20 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

be ordered as part of routine check-ups or to inform ongoing treatment decisions. 33,34 8. How Was the M3 Checklist Validated? A research group from the University of North Carolina headed by Dr. Bradley Gaynes conducted a study of 650 patients at the UNC Family Practice Clinic. 1 This study confirmed the validity of the M3 Checklist as a diagnostic tool utilizing the Mini International Neuropsychiatric Interview as a standard. 9. Who Created M3? The M3 Checklist was created in 2003 by Robert Post, MD, head of the Bipolar Collaborative Network and a psychiatrist with the National Institute for Mental Health for 30 years; Bernard Snyder, MD, Assistant Clinical Professor of Psychiatry (retired) at Georgetown University; Michael Byer, President and co-founder of M3 Information; and Gerald Hurowitz, MD, Assistant Clinical Professor of Psychiatry at Columbia University and Chief Medical Officer of M3 Information. 10. Do Other Tools Like the M3 Already Exist? Several other tests provide some functions present in the Checklist. However, the M3 Checklist is unique in eliciting patient-reported symptoms dealing with depression, anxiety disorders, PTSD, bipolar disorder, suicidality, and substance misuse in one web-based checklist and in integrating the results into a primary practice s workflow and electronic health record. M3 Checklist s exclusive availability through LabCorp s test catalogue also means it is more accessible and more easily reimbursable than other tools. 11. How are the M3 Checklist and AUDIT-C Ordered? The M3 Checklist and AUDIT-C are found in the LabCorp test catalogue at www.labcorp. com/test-menu/search. 12. What are the Advantages of the Collaboration of M3 Information & LabCorp? The collaboration between M3 Information and LabCorp brings advantages to patients and clinicians alike. Together, M3 and LabCorp are able to offer a multi-condition assessment tool that is easily accessible to clinicians and patients, seamlessly integrated into EHRs, and reimbursable under billing codes recognized by Medicare and most commercial insurance plans. Availability of assessment under this arrangement furthers the integration of mental health with general health care by providing effective and efficient mental health screening through LabCorp s extensive network of clinical settings. Individuals will receive better care and clinicians will see improved outcomes over a broad range of conditions from stroke, diabetes, and cancer to targeted mental health conditions including depression, bipolar disorder, anxiety disorders, post-traumatic stress disorder, and alcohol misuse disorder. The aggregated information stemming from the assessments will help improve population health approaches, as well. Through LabCorp s extensive network and high standard of care and M3 Checklist s emphasis on symptom identification and treatment adherence, this collaboration has the potential to produce a quantum leap in the quality of mental health treatment, which could lead to better patient outcomes, increased efficiency for practices, and significant savings for the healthcare system at large. 13. How do you implement the M3 Checklist through LabCorp? Two steps need to be completed by the practice, LabCorp and M3 Information. First, M3 will establish the practice as a client bill, and the secondly the order needs to be in a stand-alone order. When orders are placed through electronic health records (EHRs), the EHR will need to collect the order date and time and the patient s (or clinic s) email address. The email information is collected through an Ask at Order Entry prompt. The LabCorp support team will work with practices to complete these two data elements, identifying which fields to place in the order message. 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 21

References 1 Gaynes B, et al, 2010. Feasibility and Diagnostic Validity of the M3 Checklist: A Brief, Self-Rated Screen for Depression, Bipolar, Anxiety, and Post-Traumatic Stress Disorder in Primary Care, Ann Fam Med 2010:8(2)160 2 SAMHSA NSDUH 2014, Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health. https:// www.samhsa.gov/data/sites/default/files/nsduh-frr1-2014/nsduh- FRR1-2014.pdf Accessed April 10, 2017 3 Kessler R, et al, 2005. Prevalence, Severity, and Comorbidity of Twelve month DSM-IV Disorders in the National Comorbidity Survey Replication (NCSR). Arch Gen Psychiatry 2005:62(6):617 4 Wang P, et al, 2005. Twelve-month use of mental health services in the United States: Results from the National Comorbidity Survey Replication. Arch Gen Psych 2005:62,629 5 Das A, et al, 2005. Screening for Bipolar Disorder in a Primary Care Practice. JAMA 2005:293(8):956 6 Wisner K, et al, 2011. Onset Timing, Thoughts of Self-harm, and Diagnoses in Postpartum Women with Screen-Positive Depression Findings. JAMA Psychiatry 2013:70(5):490 7 Goodell s, et al, 2011. The Synthesis Project, New Insights from Research Results, Policy Brief NO. 21, 2011. Accessed April 6, 2017 http://www.rwjf. org/content/dam/farm/reports/issue_briefs/2011 rwjf69438 8 Kessler RC, et al., 2005. Lifetime Prevalence and Age-of-Onset Distributions of DSM-IV Disorders in the National Comorbidity Survey Replication Arch Gen Psych 2005:62(6)617 9 Melek S, et al., 2014. Economic impact of integrated medical-behavioral healthcare, 2014 Milliman, Inc. American Psychiatric Association. https:// www.psychiatry.org/psychiatrists/practice/professional-interests/ integrated-care Accessed March 22, 2017. 10 Hurowitz G, 2009. Feasibility and diagnostic validity of the M-3 Checklist: a brief, self-rated screen for depressive, bipolar, anxiety, and post-traumatic stress disorders in primary care. New York. Unpublished data set. Cited with permission. 11 Ball K, MacPherson C, Hurowitz G, et al. M3 Checklist and SF-12 correlation study. Best Pract Ment Health 11(1); 2015, 83-89 12 Casey BJ, Craddock N, Cuthbert BN, et al: DSM-5 and RDoC: progress in psychiatry research? Nature Rev Neurosci 14; 2013, 810-814 13 Insel TR: The NIMH research domain criteria (RDoC) project; precision medicine in psychiatry. Am J Psychiatr 171(4); 2014, 395-397 14 Frank D, et al, 2008. Effectiveness of the AUDIT-C as a Screening Test for Alcohol Misuse in Three Race/Ethnic Groups. J Gen Intern Med 2008 Jun 23(6): 781-787 15 www.phqscreeners.com/ Originally developed by Pfizer. PHQ-9 & PHQ-4 screens with all questions can be found at this site once terms are agreed to. 16 Arroll, B; 2010. Validation of PHQ-2 and PHQ-9 to Screen for Major Depression in the Primary Care Population. Ann Fam Med, 2010 Jul; 8(4): 348 353 PHQ-2: a 2-item assessment for depression, it consists of the first 2 questions of the PHQ-9. this is the last line of Purpose in the abstract 17 Spitzer, R; 2006. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. 18 https://cde.drugabuse.gov/instrument/e9053390-ee9c-9140-e040 bb89ad433d69 19 http://www2.psy.unsw.edu.au/dass/ Link to screen found on this page 20 https://www.rand.org/health/surveys_tools/mos/20-item-short-form/ survey-instrument.html this goes directly to the screen 21 Hirschfeld, R 2002. The Mood Disorder Questionnaire: A Simple, Patient- Rated Screening Instrument for Bipolar Disorders. Primary Care Companion J Clin Psychiatry 2002:4(1) 22 American Medical Association, 2016. Current Procedural Terminology, 2017, Professional Edition. American Medical Association, Chicago IL. Identifies codes & descriptions. 23 Palmetto GBA Medicare Physician Fee Schedule (MPFS) tool, 2017. Medicare Physician Fee Schedule Part B -2017 (April). States reviewed: DC +MD/VA suburbs; Manhattan, NY; & WY. Accessed May 15, 2017 http:// www.palmettogba.com/palmetto/fees_front.nsf/fee_main?openform 24 CNS Vital Signs, 2016. 2016 Reimbursement Guide: In-Office Neurocognitive Testing Procedure https://www.cnsvs.com/whitepapers/ CNSVS-Reimbursement2016.pdf 25 Aetna, Behavioral Health Medical Director, March 2017. Personal phone interview with Steve Daviss, MD. 26 HCPCS. 2017 Healthcare Common Procedure Coding System. http://hcpcs.codes/g-codes Accessed May 16,2017. Identifies codes & descriptions. 27 Centers for Medicare & Medicaid Services, March 23, 2012. Medicare Learning Network. Screening for Depression in Adults. https://www. cms.gov/outreach-and-education/medicare-learning-network-mln/ MLNMattersArticles/downloads/MM7637.pdf Accessed August 23, 2017. 28 Centers for Medicare & Medicaid Services, April 28, 2016. Medicare Learning Network. Summary of Medicare Reporting and Payment of Services for Alcohol and/or Substance (other than Tobacco) Abuse Structured Assessment and Brief Intervention (SBIRT) Services. https:// www.cms.gov/outreach-and-education/medicare-learning-network-mln/ MLNMattersArticles/downloads/MM7633.pdf Accessed August 23, 2017. 29 Substance Abuse & Mental Health Services Administration, June 4, 2015. Coding for Screening and Brief Intervention Reimbursement. https://www. samhsa.gov/sbirt/coding-reimbursement Accessed August 23, 2017. 30 Centers for Medicare & Medicaid Services, June 12, 2012. Medicare Learning Network Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse. https://www.cms.gov/outreachand-education/medicare-learning-network-mln/mlnmattersarticles/ downloads/mm7633.pdf Accessed August 23, 2017. 31 Centers for Medicare & Medicaid Services, May 2017. Medicare Learning Network. Behavioral Health Integration Services. https://www.cms.gov/ Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/ Downloads/BehavioralHealthIntegration.pdf Accessed August 23, 2017. 32 Lam R, et. al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 1. Disease Burden and Principles of Care. Can J Psychiatry. 2016 Sep;61(9):510-23 33 The University of Washington s AIMS Center website, Principles of Collaborative Accessed http://aims.uw.edu/collaborative-care/principlescollaborative-care July 11, 2017 34 Sui A, et al, 2016. Screening for Depression in Adults US Preventive Services Task Force Recommendation Statement. JAMA 2016:315(4):380 35 Cancino, R et. al. Dose-Response Relationship Between Depressive Symptoms and Hospital Readmission J Hosp Med 2014; 9 (6) 358 36 Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The Economic Burden of Adults with Major Depressive Disorder in the United States (2005 and 2010). J Clin Psychiatry 2015;76(2):155-162. 37 Melek S, et al., 2008. Chronic Conditions and Comorbid Psychological Disorders. Milliman Research Report. 22 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com

Appendix A Feasibility and Diagnostic Validity of the M-3 Checklist: A Brief, Self-Rated Screen for Depressive, Bipolar, Anxiety, 1 and Post- Traumatic Stress Disorders in Primary Care ABSTRACT Abstract PURPOSE Mood and anxiety disorders are the most common psychiatric conditions seen in primary care, yet they remain underdetected and undertreated. Screening tools can improve detection, but available instruments are limited by the number of disorders assessed. We wanted to assess the feasibility and diagnostic validity of the My Mood Monitor (M-3) checklist, a new, 1-page, patient-rated, 27-item tool developed to screen for multiple psychiatric disorders in primary care. METHODS We enrolled a sample of 647 consecutive participants aged 18 years and older who were seeking primary care at an academic family medicine clinic between July 2007 and February 2008. We used a 2-step scoring procedure to make screening more efficient. The main outcomes measured were the sensitivity and specificity of the M-3 for major depression, bipolar disorder, any anxiety disorder, and post-traumatic stress disorder (PTSD), a specific type of anxiety disorder. Using a split sample technique, analysis proceeded from determination of optimal screening thresholds to assessment of the psychometric properties of the self-report instrument using the determined thresholds. We used the Mini International Neuropsychiatric Interview as the diagnostic standard. Feasibility was assessed with patient and physician exit questionnaires. RESULTS The depression module had a sensitivity of 0.84 and a specificity of 0.80. The bipolar module had a sensitivity of 0.88, and a specificity of 0.70. The anxiety module had a sensitivity of 0.82 and a specificity of 0.78, and the PTSD module had a sensitivity of 0.88 and a specificity of 0.76. As a screen for any psychiatric disorder, sensitivity was 0.83 and specificity was 0.76. Patients took less than 5 minutes to complete the M-3 in the waiting room, and less than 1% reported not having time to complete it. Eighty-three percent of clinicians reviewed the checklist in 30 or fewer seconds, and 80% thought it was helpful in reviewing patients emotional health. Bradley N. Gaynes, MD, MPH 1 Joanne DeVeaugh-Geiss, MA, LPA 1 Sam Weir, MD 2 Hongbin Gu, PhD 1 Cora MacPherson, PhD 3 Herbert C. Schulberg, PhD, MSHyg 4 Larry Culpepper, MD, MPH 5 David R. Rubinow, MD 1 1 Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, North Carolina 2 Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina 3 Social & Scientifi c Systems, Inc, Silver Spring, Maryland 4 Department of Psychiatry, Weill Medical College, Cornell University, White Plains, New York 5 Department of Family Medicine, Boston University School of Medicine, Boston, Massachusetts CONCLUSIONS The M-3 demonstrates utility as a valid, efficient, and feasible tool for screening multiple common psychiatric illnesses, including bipolar disorder and PTSD, in primary care. Its diagnostic accuracy equals that of currently used single-disorder screens and has the additional benefit of being combined into a 1-page tool. The M-3 potentially can reduce missed psychiatric diagnoses and facilitate proper treatment of identified cases. Ann Fam Med 2010;8:160-169. doi: 10.1370/afm.1092. 155 Gibbs Street, Suite 522 Rockville, MD 20850 301.444.4400 M3Information.com 23

M3 Information 2017. The contents of this book may not be reproduced, in whole or in part, without the express written consent of M3 information.